Understanding MDR and IVDR Post Market Surveillance

In our recent webinar, part of our four-part MDR and IVDR compliance series, we will explore the critical elements of Post Market Surveillance (PMS) under the MDR and IVDR, including data collection, reporting adverse events, and how PMS feeds into continuous product monitoring. The session will cover how manufacturers can implement an effective PMS system to meet regulatory requirements and maintain patient safety. Daniëlle will also provide insight into how PMS ties into the broader regulatory framework. The session will end with a Q&A, so be prepared with any questions related to post-market activities.

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MDR and IVDR Post Market Surveillance Topics Covered

Overview of Post Market Surveillance under the MDR and IVDR

• Post Market Surveillance vs. Market Surveillance: We explored the distinction between PMS (manufacturer’s responsibility) and market surveillance (regulator’s role). Both are critical to ensuring that medical devices continue to meet safety standards after reaching the market. 
• PMS as a Continuous Process: It’s crucial to treat PMS as an ongoing process, not a one-time event. This involves both reactive (complaints, non-conformities) and proactive (clinical literature, competitor data) inputs to assess the performance of your device. 
• PMS System Requirements: Under MDR, manufacturers must have a comprehensive plan in place for PMS, which should cover: 
  • Serious incidents 
  • Non-serious complaints 
  • Risk management and corrective actions 
  • Clinical evaluation and post-market clinical follow-up (PMCF) 
• Reporting and Auditing: The webinar covered the importance of documenting and reporting PMS findings, particularly the difference in requirements for class 1 devices (where reporting frequency can be defined by the manufacturer) and class 2A/B and class 3 devices (which have stricter reporting timelines). 
• Post Market Clinical Follow-Up (PMCF): Even for devices with established technology or no residual risk, a PMCF plan must be in place. This is now mandatory under MDR. 
• Challenges in PMS: Many manufacturers face challenges with resources and ensuring the quality and completeness of PMS data. The webinar discussed strategies to improve these areas. 
• Audience Poll Results: 
  • Biggest Challenge in PMS: Limited resources 
  • PMCF Activities: 70% of participants are actively conducting PMS and PMCF for devices already on the market. 
  • Impact of EUDAMED: Most manufacturers are not affected by the absence of EUDAMED in PMS activities. 

Notable Non-Conformities for MDR and IVDR Post Market Surveillance:

• Lack of documented PMS plans or failure to follow defined procedures 
• Inadequate interaction between PMS and risk management, clinical evaluation, or CAPA 
• Missing or incomplete post-market clinical follow-up plans 

Conclusion:

We encourage manufacturers to define clear MDR and IVDR Post Market Surveillance and ensure that all documentation is in place, from PMS reports to communication mechanisms with notified bodies. The goal is to provide clear evidence that the benefit-risk ratio of the device continues to outweigh any risks.

We hope this webinar series has helped clarify the intricacies of MDR compliance. If you missed any sessions, don’t worry—recordings and materials are available. Be sure to follow us on LinkedIn for the latest updates, resources, and more webinars in the future!